Drug · Small Molecule

Ribociclib

CI-DRUG-00000518Explore in graph →NCIt C95701 CHEMBL3545110 CIViC Approved

Regulatory

Approvals (11)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Malignant Breast Neoplasm	Early breast cancer Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.	approved	Aug 22, 2017	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	65	33	24	144	11	CA, EU, US	Mar 13, 2017	Dec 21, 2010
Malignant Breast Neoplasm	Approved	Phase 4	34	18	14	63	3	EU, US	Mar 13, 2017	Sep 6, 2013
Malignant Lung Neoplasm	Phase2	Phase 2	3	2	0	6	0	—	—	May 14, 2015
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	2	1	0	8

Curated evidence

Clinical evidence (12)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–12 of 12 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
CDK4 Overexpression2
Palbociclib + Ribociclib

Clinical trials

Trials with this intervention (155)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 155 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05867251	Study of AVZO-021 in Patients With Advanced Solid Tumors	recruiting	Phase 1 / Phase 2	430	Avenzo Therapeutics, Inc.INDUSTRY	2	Sep 28, 2026	clinicaltrials
NCT07391774	Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

Molecule

Record

Kind: Small Molecule
Mechanism: Cyclin-dependent kinase 4 inhibitor; Cyclin-dependent kinase 6 inhibitor
Targets: 2 genes
UNII: BG7HLX2919
Aliases: 7-Cyclopentyl-N,N-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide, Kisqali, KISQALI, LEE 011, LEE-011, LEE011, LEE-011A, LEE011A, NVP-LEE011, Ribociclib, Ribociclib Succinate

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (4)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EF02	RIBOCICLIB
DIN (Health Canada)	02473569	KISQALI
DPD drug code